September 19, 2018

Smart Tech: Wearable Medical Devices

Smart Tech:  Wearable Medical Devices 2017 – 2020

Smart technologies will continue to drive the ever-growing medical wearable device market in 2017 and well into the future.
The global medical wearable devices market topped $3.2 billion in revenue in 2015, according to Mordor Intelligence, which expects the market to surpass $7.9 billion in 2020 as the industry continues to grow at a healthy CAGR of 19.8 percent during that period.
wearablemedicaldevices_frank-magliochetti-reportWearable medical devices, known simply as “wearables,” are small pieces of equipment featuring sensors that attach to the body. These sensors detect and monitor changes in specific body signatures produced by various body systems and organs. Early wearable technology allowed consumers to monitor vital signs. Today’s wearables allow users to monitor food intake, activity, and sleep levels. Tomorrow’s devices may provide continuous monitoring of glucose levels, smart clothing for infants, and smart EKG necklaces for those with heart problems.
Wearables have the potential to fill a number of applications in remote patient monitoring, sports and fitness monitoring, and home healthcare. Simplified usage of these devices, coupled with the ability to synchronize with smartphones and tables, assisted growth in this segment.
Global Wearable Devices Market- Market Dynamics

There are immense potential socio-economics of wearable medical devices for multiple sectors. Fitness devices that encourage the users to exercise can significantly reduce healthcare costs, for example.

Investors are focusing on a wide variety of projects, ranging from downloadable apps to improving the size, cost and sensitivity of sensors.wearablemedicaldevices_frankmagliochettireport

Several factors propel the growth of the global wearable market. Technological innovation is perhaps the most important factor, as these advancements lead to the introduction of new products.
Diabetes and other chronic diseases are rising at a seemingly uncontrollable rate. Wearable devices will play an increasingly important role in helping doctors and patients manage chronic diseases.

Developers make wearable devices easier to use and simplify interpretation of the data collected. Simplicity encourages use.
Market penetration of smartphones, smart watches and other wearable devices will promote the use of wearable medical technology. These devices have already penetrated the market deeply, with the worldwide smart watch shipments reaching about 25 million in 2015.

Some factors, such as reimbursement issues and high device cost, will restrain the medical wearables market somewhat but the effect should be minimal, as demand should remain high.
Several companies are already exploiting the growing interest in medical wearable technology by creating affordable products that offer high value to users and their healthcare partners.

Some of the key players already operating in the medical wearable device market include:
• Dräger
• Fitbit Inc.
• Intelesens Ltd.
• Lifewatch AG
• Omron Corporation
• Polar Electro
• Philips Electronics
• Withings SAS
These wearable manufacturers will likely improve hardware in existing products and create sturdier devices within the next few years. Hardware and device ifrankmagliochettireport_wearable-medical-devicesnnovations may include larger and easier to read displays, extended battery life, waterproof hardware, and compatibility with GPS and other sensors included in a standard smart phone. Software innovations may include advanced monitoring systems and improved patient care software, such as breathing exercises and on-demand nutrition counseling.
The wearable market is expanding because the devices are autonomous, which makes them easy to use, and non-invasive. It is also growing because of its ability to help prevent and manage chronic diseases.

Source
https://www.mordorintelligence.com/industry-reports/global-wearable-medical-device-market-industry

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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2017 Trends in Cancer Care Drugs

2017 Trends in Cancer Care Drugs

Frank Magliochetti Report

Cancer drug development will continue to be a key focus area in 2017. While the number of new cancer frank-magliochettireport_2017_cancer-stopcases in the United States each year remains constant at about 1.7 million, the American Cancer Society says that the cancer death rate has plummeted 23 percent since the early 1990s. This is largely due to improved diagnostics, early detection, and new medications and treatments.
There has been extensive development of cancer medications in the past decade, and the development of oncology drugs will continue to be a key focus area in 2017. There are several important factors affecting cancer drug development in the upcoming year, including a large number of clinical trials already underway, the possibility of shortened regulatory approval time, and increases to consumer cost.

Cancer Drug Development

Extensive development of cancer medications is already underway, and much of this development will continue into 2017. New medicines, just launched within the past five years, now treat more than 20 types of tumors, according to a new report from IMS Institute for Healthcare Informatics. In fact, there were 70 new oncology treatments for more than 20 uses launched from 2011 to 2015. Further research of these new agents will likely result in approval for subsequent indications and provide therapeutic options to more patients.2017_cancertrends_frankmagliochetti
While there is substantial opportunity in the cancer drug industry, there will also be stiff competition in 2017. More than 500 companies are actively engaged in developing oncology drugs. Collectively, these companies are pursuing nearly 600 indications, primarily for non-small cell lung cancer, breast, prostate, ovarian and colorectal cancers.
This giant and diverse group of pharma companies has created a healthy pipeline of oncology drugs in clinical development. In fact, the pipeline of cancer drugs in clinical development has grown more than 60 percent over the past ten years.
Nearly 90 percent of these drugs are targeted agents, and the trend towards targeted agents will likely continue. There are more than 120 clinical development project underway for targeted agents to treat non-small cell lung cancer and melanoma, for example, and each features different mechanisms and combinations that promise new benefits.
It is taking less time for new cancer treatments to receive regulatory approval. The median time from patent filing to approval for cancer drugs in the U.S. dropped from 10.25 years in 2013 to 9.5 years in 2015. Initiatives such as the FDA Breakthrough Therapy designation expedite development and review of drugs that treat serious or life-threatening diseases or conditions.

Patient Costs may Rise

In campaign speeches, the new President-elect of the United States has promised changes to the Affordable Care Act, and these changes may increase patient costs. Average treatment costs for a year of cancer care for patients with commercial insurance plans rose 19 percent to $58,097 in 2014.  Cost increases in 2017 may depend on where the patient receives care. Outpatient services account for more than half of the total costs, according to the IMS report, and the average combined total cost of all  drugs used by the patient accounts for 28 percent of the total cost of care.
Average costs for administering cancer drugs are usually twice as high when patients receive treatment in hospital outpatient settings than when they receive care in physician offices. Higher costs for outpatient care increases patient cost responsibility. Coupons and other forms of assistance may offset the cost to consumers.

Source

http://onlinelibrary.wiley.com/doi/10.3322/caac.21332/abstract
https://morningconsult.com/wp-content/uploads/2016/06/IMS-Institute-Global-Oncology-Report-05.31.16.pdf

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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Pharmaceutical Trends for 2017: Biosimilars

Pharma Trends 2017:  Biosimilars

Frank Magliochetti Report

The FDA approved 56 new drugs in 2015 and, of these, 33 were specialty drugs and 23 were traditional. One was a biosimilar. Development, approval and acceptance of biosimilars may become an important trend in 2017.
The FDA is approving more specialty drugs than ever before and specialty medicines will likely face more competition in 2017. Increased FDA approval and frankmagliochetti-report-pharma-trends-biosimilarsdiscoveries of medications to treat orphan conditions and cancer will fuel competition. Biosimilars could overcome development hurdles and increase this competition even more.
Acceptance of biosimilars has been slow in the past. One of the reasons for the reluctance is that the development of biosimilars is different from that of generic drugs. Generic drugs for small molecules have a relative simple chemical structure that makes it easy to reproduce an identical chemical. It is more difficult to make a protein or peptide identical to the original biologic agent because of differences in the sugar residues attached to the protein, for example, or differences in the protein folding that make it unpredictable. This means that, even though a biosimilar has an identical peptide chain, it may not have an identical effect. These factors complicate the process of making biosimilars and increase the risk for problems.
Physician acceptance has been slow too but, as the cost of other medications rise, biosimilars will seem more attractive.
Approval of Biosimilars in 2015 and 2016
Biosimilars, which are products the FDA will approve with evidence that the medication up for approval is highly similar to an already-approved reference product, will probably continue to gain traction in 2017. The FDA has approved four biosimilars as of October 2016.
Zarxio is similar to Neupogen, according to an article published by Managed Healthcare Executive, except the biosimilar has a 15 percent lower list price. Both drugs treat low white blood cell counts associated with cancer and its treatment. The FDA approvedZarxio, made by Sandoz, in March 2015.
Inflectra is similar to Remicade to treat Crohn’s disease and ulcerative colitis. The FDA approved Inflectra in April 2016 but, due to litigation, the launch date is uncertain.
Erelzi, also made by Sandoz, is similar to Enbrel to treat arthritis. The FDA announced approval of Erelzi in August of 2016 and the expected launch date of biosimilar-frankmagliochetti-pharma-trends-2017February 2017 may be delayed.
Amjevita, by Amgen is similar to Humira and is for the treatment multiple inflammatory diseases. Amjevita became the fourth biosimilar drug to gain approval in September 2016. Launch date is set for March 2017 but may experience delays.
There are several biosimilars awaiting approval, including:
• Filgrastim by Grastofil, Apotex
• Pegfilgrastim by Apotex
• SB2 infliximab by Merck/Samsung Bioepis
• CHS‐1701 by Coherus Biosciences
• Epoetin alfa by Retacrit, Pfizer
The need for biosimilars will grow as the need for other drugs, especially cancer drugs and orphan drugs, increases. Doctors diagnose about 1.7 million cases of cancer each year, yet the death rate has fallen 23 percent since the early 1990s, partially due to new medications and treatments. The introduction of biosimilars could reduce cancer death rates even further.
Biosimilars may become one of the strongest trends in the pharmaceutical industry in upcoming years, as biosimilars have the potential to lower the cost for safe and effective treatments for a wider number of patients. Increased development of biosimilar cancer drugs is possible as some biopharmaceuticals lose patent protection.

Source
https://www.uspharmacist.com/article/record-number-of-fda-new-drug-approvals-in-2015
http://www.zarxio.com/index.jsp
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/five-specialty-pharmaceutical-trends-watch
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
http://www.erelzi.com/
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
http://pi.amgen.com/united_states/AMJEVITA/AMJEVITA_mg.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm522243.htm

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Genome Editing – Progressing Trend

The Rush for Genome Editing

Frank Magliochetti Report

The Rush for Genome Editing

Gene-editing technology has sparked a frenzy of competitors fueled to develop the first of what may be thousands of treatments for genetic disorders.

From science fiction of movies like Jurassic Park to the reality of GMO foods, the concept of customizing plants, animals and even human genomes has mesmerized our imagination and culture for decades. This obsession is not surprising considering the remarkable impact of genetic engineering on our lives, and the promise it may hold for our future.crispr-genome-editing-franlmagliochetti-report_northandoverma

Modifying the genes of an organism is no easy task. It’s not as simple as removing the parts you do not like with an eraser. It involves making changes at a molecular level that are both complex and challenging.

One concern among scientists is the modifications made in human germline cells – i.e. the sperm or the egg. These are genetic changes that would actually be passed on through generations and the fear is that there could be unexpected side effects. Couple that with the ethical concerns of people misusing this technology to intentionally modify the genome to make “designer babies” with enhanced characteristics. These are some real concerns that are causing scientists to pause and weigh the pros and cons of use of this technology.

More and more companies are racing to stay ahead of the trend and become the leaders in the field.

In Cambridge MA, Intellia Therapeutics Inc. has a 65,000 square foot build out underway, however, it is still planning to functioning while under construction.

Intellia is one of a trio of startups in the Cambridge area working locally in the biotech niche known as CRISPR-Cas9. The gene-editing technology was frank-magliochetti-report_intelliadiscovered just four years ago.

Drug development historically has been a slow process – it often takes more than a decade to bring a medicine from lab to marketplace. But that’s changing, thanks to new machines that can screen drug targets faster and an entrepreneurial environment that’s more akin to high-tech than Big Pharma.frankmagliochettireport_genome_editing

Intellia has high-profile collaboration deals with Swiss drug giant Novartis AG and Regeneron Pharmaceuticals Inc. of Tarrytown, N.Y. It raised $108 million in an initial public offering in May. Their scientists are working on gene-editing treatments for everything including the hepatitis B virus to a rare form of blindness. If all goes well, it could move its earliest drug candidates into clinical trials within 18 to 24 months.

Competitors for Intellia include Editas Medicine and Crispr Therapeutics Inc. both completed their own IPOs this year. There are more to come: all with the heightened interest of investors. These companies are in a race to develop the first treatment based on gene editing.

Genome editing is going to be a hot trend to watch in 2017 and for many years to come.

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

frankmagliochetti_ParcaeCapital

Genome Editing – CRISPR

Frank Magliochetti Report:   CRISPR

CRISPR trials just may be one the most important healthcare industry breakthroughs of this generation

Frank Magliochetti

Almost every year, a new disease is introduced in the world which affects the population of our country. It would be wrong to say that people living in rural areas may be more prone to catch diseases than those who are living in the city. The fact is that no matter where you live or how Frank-Magliochetti_crisprhard you try to protect yourself from the outside world, there are some in-house diseases that may catch up to you.

Once such disease that can strike anyone at any time is cancer which arises through our genetics.   A disease that in some cases runs down from generation to generation which may strike no matter what we may do to help prevent it.  It is something we all dread.

A study conducted on genetic based cancer diseases was conducted in the US and finally was granted access for testing on humans on June 21st.   The NIH (National Institute of Health) gave the green light to start testing the CRISPR-Cas9 trial on humans so that help from T Cells could be enlisted to protect the body.

To understand the trial, first, one needs to understand what exactly CRISPR-Cas9 is. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) is a drug derived from Streptococcus pyogenes, which enabled the researchers to make permanent mutations. This introduces double stranded healing breaks in cells to activate the repair pathways in a human body. They adapt immunity in certain archaea and bacteria, which allow organisms to invade and eliminate genetic material.

This disease was discovered in 1989 but until 2007 its symptoms were unknown. 2016 has brought new hope for people to live a healthy life. The trial will be funded by Sean Parker, a tech entrepreneur who has a $250 million dollar cancer treatment center; The Parker Institute for Cancer Immunotherapy.

There have been other trials conducted but the problem with them was that the T Cells, which were reintroduced to a person’s body were not that effective, however, they did kill the NY-ESO-1, the T Cells stopped proliferating and became less effective. crispr-magliochetti

There are many hospitals all over the world that are holding CRISPR trails. Some trials were started at the beginning of August while others are set to start in September.

Hospitals such as Massachusetts General Hospital located in Boston have been conducting tests on genome editing since 2013. This is one of the oldest hospitals in Boston and gets close to 100,000 patient visits per year. There are even chances that MGH affiliated laboratories will also conduct genome editing trials.

Many more hospitals based in Boston have announced that with proper funding, they will start genome editing trials in 2017. Since the trials are so expensive, scientists will pick patients who are immune to Cas9 enzyme.

The discovery and trials of CRISPR is one of the best advancements in medical history. Though the patients for the trial will be chosen in small numbers, people living in fear that their life may end after four or five years due to a genetic illness like Leukemia may now have new hope of living a healthy and happy life.

The content below was aggregated from a Boston Globe opinion piece by Jim Kozubek please click the link to head to the official site to read the rest of the post.

https://www.bostonglobe.com/ideas/2016/09/03/crispr-and-capitalists/uX8NuPsva5L2iNI2DCBArJ/story.html

CRISPR and the capitalists

CRISPER-CAS9 IS A method of manipulating DNA that is transforming medicine and science. It is both popular (“molecule of the year!”) and dangerous (researchers have received threats from GMO activists). It is also wildly lucrative.

The first clinical trial of these tiny molecular scissors may begin by the end of the year. Meanwhile, two camps, the Broad Institute — where I held affiliation for nearly three years — and University of California at Berkeley and researcher Emmanuelle Charpentier, are locked in a patent showdown that will play out in early 2017 with perhaps a billion dollars at stake.
Society treats science as a public trust by funding it through taxes, but perhaps it shouldn’t do so indefinitely. One of the subliminal things that the CRISPR-Cas9 legal showdown tells us is that academic-industry partnerships may one day be mature enough that science may begin to forgo its tax base.

In 1943, President Franklin D. Roosevelt directed his wartime chief of research, Vannevar Bush, to find a way to extend funding after the war. In a document with soaring language entitled “Science the Endless Frontier,” Bush laid out the argument for robust federal funding engines through the National Institutes of Health, the creation of the National Science Foundation, and what would become a briskly expanding network of research scientists throughout the United States.
Read More – CLICK HERE

Frank Magliochetti is Managing Partner for Parcae Capital.

  • North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry.  Frank plans to release a new site dedicated to the industry.  He currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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News

Frank Magliochetti  Radio Show Host?

The summer months were quite busy for the managing partner at Parcae Capital  Frank Magliochetti – Frank has been on the move!

Frank was uncanny with the pick hits and content on Absolute Day Traders .  Take for example the hot pick hit company OPKO Health.  The ongoing posts featuring Opko Healthone of Absolute Day Trader Picks  pick hit companies were dead on as the company started hitting it big late August and fast became trending on numerous sites as a must have addition to your watch list.    Mr Magliochetti was way out in front of this pick hit compan.  For months leading up to OPKO making headlines Frank was posting about the important activity going on there.    – Keep an eye on the pick hits from Frank  on Absolute Day Traders!

Frank found time to co-host the popular internet business radio show MYOB on the UR Business Network with show creator and UR Business Network  founder Rick Brutti.

Frank welcomed two innovative pioneers as guests to speak on their respective fields, both  guests made for some interesting and lively conversation.

Meet Peter Weinstein founder and SEO of  One3 IP.

LISTEN TO THE INTERVIEW – CLICK HERE!

Here is some information Boston Financial Guide curated from the One3 IP  website to share with you while listening to the interview. We urge you to visit their website for more details about  One3 IP by clicking HERE.

ONE3IP_FRANKBAGLIOCHETTI

About Us

One3 IP Management was founded based on several key principles that can be summed up as, One3 IP guarantees that it will focus on our clients’ needs and will continually strive to provide our clients the best service, the best results at a price that our clients can afford.  In a nutshell, our clients’ needs will always come first.  Contact One3 IP and let us show you how it is done.

Core Values

One3 IP Management views your intellectual property differently than general practice and patent law firms. To One3 IP, its clients are partners, whose success is One3 IP’s goal. One3 IP is driven to bring the highest quality work to its clients by focusing on the client’s needs.

Our Clients

No matter what industry or technology your company practices, One3 IP can handle your intellectual property and licensing needs. One3 IP represents clients in many different industries around the world, including in biotechnology, pharmaceuticals, medical information, medical device, hardware and software, personal products, sportswear and other technology fields.

Who We Are

One3 IP is an intellectual property management company that works as a partner with its clients to help them protect their intellectual property in a manner that obtains the broadest patent protection available, while also helping its clients establish, implement and follow through on the procedures necessary to protect non-patented trade secrets in a legally enforceable manner. By doing this, One3 IP is able to maximize the monetary and protective value of its clients intellectual property. One3 IP also handles its clients licensing needs, from simple Confidentiality Agreements to complex Research and Development Collaboration Agreements. Let One3 IP be your company’s partner. One3 IP does all this in a cost effective manner that fits within its client’s budget.

Meet  Xenetic CEO Scott Maguire and listen to what Xenetic is doing and how it may  impact the Boston Financial landscape.

CLICK HERE – to listen to the interview!

xenetic_bioscience-Logo

Xenetic is a leading UK-based bio pharmaceutical company providing leading-edge expertise in the development of a whole new generation of drugs, cancer therapies and vaccines.

Working with some of the largest pharmaceutical organisations in the world, Xenetic provides specialist delivery solutions to improve the efficacy and performance of drugs and vaccines in a number of key medical areas including oncology.

We are also actively developing our own pipeline of next generation biotherapeutics based on our proprietary PolyXen,Oncohist and ImuXen platform technologies.

Here are some of the facts curated by Boston Financial Guide from  the Xenetic website

Product Pipeline

Protein drugs and vaccines

Xenetic’s biopharmaceutical pipeline contains a range of product candidates which are currently under development either in-house or with biotechnology and pharmaceutical partners.  The products in Xenetic’s pipeline have a multi-billion dollar market potential.

Frank Magliochetti is managing partner at Parcae Capital.

North Andover MA based Parcae Capital offers personalized investment banking services for emerging growth companies. They specialize in finding companies which have leading edge technology, services or intellectual property in the healthcare, media and alternative energy space. Parcae Capital assists both public and private companies in preparing to raise private and public capital for all phases of growth. Parcae Capital also offers comprehensive assistance in mergers, acquisitions and related services. Their work out group specializes in business restructuring and recapitalization.